Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:

resistance [ Time Frame: week 72 ]

To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks

Secondary Outcome Measures:

virologic failure [ Time Frame: week 72 ]

To determine the frequency of virologic suppression defined as HIV-RNA <400 copies/ml over 72 weeks To determine the frequency of virologic failure as HIV RNA ≥1000 copies/ml over 72 weeks To evaluate predictors of virologic failure

drug resistance [ Time Frame: week 72 ]

To assess HIV drug resistance patterns by virtual phenotyping

ARV drug levels [ Time Frame: week 72 ]

To correlate ARV drug levels between plasma and hair samples To correlate hair ARV levels with virologic responses and measures of adherence

Biospecimen Retention: Samples Without DNA

Blood and hair will be used for therapeutic drug monitoring (TDM). Blood drawn at every visit will be used to assess CD4 count, viral load, and other basic chemistry test panel. If necessary, drug resistant tests will also be carried out on the blood samples.

Asian HIV-positive children <18 years old who are receiving HIV care at one of the participating TREAT Asia Pediatric HIV Observational Database (TApHOD) sites that have been identified for TASER-P participation will be monitored for treatment failure of second-line ART

Detailed Description:

Children in resource-limited settings are increasing experiencing treatment failure, as defined by virologic, immunologic, and/or clinical criteria. There are few studies of HIV resistance mutations in children failing first line NNRTI therapy in resource limited settings. The emergence of treatment failure and drug resistance in children on ART emphasizes the urgency for developing evidence-based second-line and salvage treatment strategies. Pediatric treatment is complicated by a number of factors, including having fewer numbers of ARVs approved by drug safety agencies and the lack of pediatric formulations. This further shortens the list of available second-line ARVs as compared to adults.

Despite the growing number of children on second-line therapy worldwide, there are limited data on efficacy of second-line PI therapy in children after NRTI-NNRTI failure. There are currently no options for third-line/salvage regimens for children in resource-limited settings. New drugs and drug classes are approved for use in children by the US FDA but are not routinely available outside of high-income settings.

Also, there are no data on the resistance patterns of children failing second-line therapy in resource-limited settings to guide clinical management and ARV procurement. Clinicians need evidence-based guidelines for how to manage children with treatment failure, and access to the drugs necessary to construct potent and durable third-line regimens.

TASER-P is a longitudinal observational cohort study to monitor for treatment failure to second-line ART in Asian children.

Eligibility

Ages Eligible for Study:

up to 18 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

HIV-positive children <18 years old who are have switched to or treated with second-line ART at one of the participating TREAT Asia Pediatric HIV Observational Database (TApHOD) sites.

Criteria

Inclusion Criteria:

Age < 18 years old

Have confirmed HIV infection

Are being switched to or treated with second-line ART. Second-line ART is defined as the second regimen with a major antiretroviral class switch. For example, a switch from an NNRTI-based to a PI-based regimen or vice versa

Caregivers give informed consent. Children will be asked to give assent if they know their HIV status and have reached the minimum age to give assent according to each site's institutional review board regulations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788891